Assessment of Noninvasive Neuromodulation in a Group of Traumatic Brain Injured Patients and Healthy Volunteers

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

Background: Severe traumatic brain injury, particularly diffuse axonal injury (DAI), often leads to lasting neurological issues. Cerebral dysfunction in DAI can be evaluated by monitoring cerebral electrical activity (CEA) through EEG. The radio electric asymmetric conveyer (REAC) is a noninvasive method designed to rebalance cellular polarity via endogenous bioelectric fields and modulate CEA. This technique may alter CEA, which can be detected using quantitative EEG (qEEG). Objective: To assess qEEG changes following DAI and brain wave alterations after a REAC protocol in this group. Methods: In this prospective, randomized, double-blind clinical trial, DAI patients will be assigned to active or sham groups for 19 sessions of either true or sham REAC following ICU discharge. Interventions include one Neuro Postural Optimization session and 18 NPPO-BWO-G sessions (up to four per day). The main outcome is to evaluate changes in qEEG patterns through population brain electrical mapping after REAC therapies.

Key facts

Study ID

NCT07373366

Run by

University of Sao Paulo

People needed

60

Starts

2025-04-01

Expected to finish

2027-05-01

Last updated by the study team

2026-01-28

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• DAI diagnostic and consent for participation with the next of kin for each eligible patient

You may not qualify if…

• Open TBI
• History of chronic neurological conditions

Where it is running

• Hospital das Clínicas da FM-USP — São Paulo, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.